A Look At Legal Trends in Pharmacy Practice
Pharmacy practice has changed significantly in the past 10 years. There’s been a large shift as the industry becomes increasingly consolidated and mail-order pharmacies continue to take a larger share of the national prescription volume. In addition, pharmacists participate in more patient care activities like conducting MTMs, dispensing travel vaccines and contraceptives, and doing point-of-care testing.
Pharmacy has changed in smaller ways too, often in response to shifting consumer demand and growing public health threats. Here are some of the more recent trends in pharmacy legislation and ways different states are addressing these issues.
Working conditions
It’s no secret that meal breaks for pharmacists are long overdue. Most of us who have worked in retail pharmacy have worked for 8, 10, or 12 hours or even longer without a meal break (or enough time to go to the bathroom). Not only does this contribute to burnout, but also it can significantly increase the risk of a medical error.
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Many states have taken action on this issue. Here are some examples:
Massachusetts and Florida have legislation or rules allowing, but not requiring, meal breaks for pharmacists.
North Carolina implemented rules as far back as 2006, capping shifts to 12 continuous hours and requiring meal breaks, while Minnesota and Virginia passed similar legislation in 2017.
In 2020, Illinois passed perhaps the most aggressive legislation to date in this area. It requires pharmacists to take meal breaks; caps shifts to 12 continuous hours; requires pharmacists who work 6 or more hours to take a 30-minute meal break, plus an additional 12-minute break; and requires an additional 15-minute break for any pharmacist working 12 hours. Pharmacists must also be given access to a private break room if one is available.
In 2021, a bill was introduced in New York that an additional pharmacist is required to be on staff when more than 200 prescriptions are dispensed. The proposal, known as Senate Bill S162, is currently in the state’s committee for higher education.
Just this month, a bill was also introduced to the California state Senate banning productivity quotas placed on pharmacists, not only for prescriptions, but for any services that require a pharmacist or pharmacy technician license.
Dispensing opioids and controlled substances
In 2018, Florida passed new legislation designed to curb the prescription opioid epidemic. The legislation limits prescription opioids to 3 days — unless the provider writes either “Acute Pain Exception,” in which case they can prescribe up to 7 days, or “Non-Acute Pain” for treatment of pain that is not acute.
In total, 33 states have passed laws limiting the days supply of Schedule II or opioid prescriptions, and 36 states mandate or allow pharmacists to check a patient’s identification before dispensing such medications. This infographic provides a great overview of key aspects of each state’s opioid and controlled substance regulation. A more detailed overview of each state’s opioid prescription limits, with links to the regulation, can be found here. Considering the gravity of the opioid epidemic, it’s likely that more states will follow suit with their own legislation.
Missouri remains the only state to not have a statewide prescription drug monitoring program, though numerous counties within the state have implemented programs of their own. There is still ongoing debate within the state and bills have been introduced before, but to date no legislation has been passed.
E-prescribing
New York caused quite a stir when in 2012 it became the first state in the nation to both mandate e-prescribing and put penalties in place for noncompliance. Many physician societies even wrote an open letter in 2015, only two months before the law was to take effect, urging the NYS Department of Health’s acting commissioner to delay the requirement.
Since then, nearly 30 states have passed e-prescribing laws that are either already in effect or have scheduled effective dates. A state-by-state breakdown of e-prescribing legislation can be found here. For Maryland and Utah, though, the mandates don’t go into full effect until 2022, while in California and Colorado it is not until 2023. Nebraska, New Hampshire, and New Jersey have bills that are currently being debated.
As a pharmacist, one of the biggest challenges to e-prescribing of controlled substances is when we do not have the medication in stock. Typically, the patient would take the paper prescription to another pharmacy, but with e-prescribing the doctor could be stuck sending it to multiple pharmacies. The latest SCRIPT standard, which went into effect in January, provides more options for pharmacists to electronically communicate with prescribers and with other pharmacies.
Product substitution
Product substitution has always been a tricky topic for pharmacists, and in my opinion, a tricky area for Boards of Pharmacy to regulate. If a doctor writes for doxycycline hyclate, is it OK to substitute with doxycycline monohydrate What if the doctor writes for Proair — can the pharmacist substitute that with Ventolin?
Most of us would say both substitutions are usually fine from a clinical perspective (even if they aren’t necessarily AB-rated), but it’s difficult to create legislation that addresses each unique scenario. In the case of doxycycline, the different salts are clinically interchangeable, but the same cannot be said for metoprolol or nitrofurantoin, for example. Even dispensing a generic instead of a brand (or even a different generic) can lead to problems for some patients, like in the case of warfarin or levothyroxine, but at the same time nobody wants legislation that requires a phone call to the doctor to substitute furosemide for Lasix.
States have taken a variety of approaches on this issue. Most states refer to the FDA’s Orange Book to guide product substitution. Many states expand on this “positive formulary” and also maintain a “negative formulary” and/or a narrow-therapeutic index drug list that prohibits generic substitution without provider and/or patient consent.
Perhaps the hottest topic right now in the world of product substitution is around biosimilars, a biologic product that is highly similar, and has no clinically meaningful differences from an existing FDA-approved reference product. The FDA has created a Purple Book that lists all biosimilar and interchangeable products, along with its reference product. So far, 45 states and Puerto Rico have passed legislation establishing standards for product substitution with biologics. The only states that have not are Alabama, Arkansas, Maine, Mississippi, and Oklahoma, along with the District of Columbia. I would be on the lookout for regular changes to the law around biosimilars, especially considering the projected growth of the market.
The bottom line
Pharmacy practice has and always will work to meet the needs of the public, with regulation evolving to reflect changing practice. States often look to each other and share information through NABP to discuss regulatory strategies, so watch for regulatory updates to these current issues in your state. It’s a good idea to read your Board of Pharmacy Newsletter, if your state has one, so you will be ready for any changes coming your way.
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